UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051203 |
|---|---|
| Receipt number | R000058375 |
| Scientific Title | Association of attenuation imaging coefficient and shear wave elastography, and biochemical markers in evaluation of liver steatosis and elasticity |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/31 10:22:49 |
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Basic information
Public title
Association of new echo algorithms and biochemical markers in evaluation of fatty liver and elasticity
Acronym
Association of liver steatosis, elasticity and biochemical markers
Scientific Title
Association of attenuation imaging coefficient and shear wave elastography, and biochemical markers in evaluation of liver steatosis and elasticity
Scientific Title:Acronym
Association of ATI, SWE and biochemical markers
Region
| Japan |
Condition
Condition
nonalcoholic fatty liver disease NAFLD, metabolic dysfunction-associated fatty liver disease MAFLD
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association of ATI,SWE and biochemical markers
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative measurement of Attenuation imaging ATI and 2D-Shear Wave Elastography SWE by ultrasound device and determination of serum biochemical markers collected on the same day
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
individuals who take regular check ups
Key exclusion criteria
individuals who do not want to participate in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Ai |
Organization
Juntendo University Urayasu Hospital
Division name
clinical laboratory medicine
Zip code
2700021
Address
2-1-1 Tomioka, Urayasu, Chiba
TEL
0473533111
t-ai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | So |
Organization
Juntendo University Urayasu Hospital
Division name
clinical laboratory medicine
Zip code
2700021
Address
2-1-1 Tomioka, Urayasu, Chiba
TEL
047-353-3111
Homepage URL
a.so.fv@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
internal
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu, Chiba
Tel
047-353-3111
a.so.fv@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058375
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